NCT07854405
A Clinical Study on the Synergistic Effects of Zhen-Qi-Jie-Du Granules in Palliative Care for Advanced Colorectal Cancer
Descripción
Does Zhen-Qi-Jie-Du Granules plus chemotherapy prolong progression-free survival compared with chemotherapy alone? Does Zhen-Qi-Jie-Du Granules improve disease control rate, objective response rate, cancer-related fatigue, myelosuppression, quality of life and traditional Chinese medicine syndrome for participants receiving chemotherapy? What medical problems and side effects do participants experience when taking Zhen-Qi-Jie-Du Granules alongside chemotherapy? Researchers will compare chemotherapy plus Zhen-Qi-Jie-Du Granules (intervention group) versus chemotherapy alone (control group). Participants may enter either a randomized controlled trial cohort or an observational cohort according to their own willingness.
Participants will:
Receive investigator-selected first-line, second-line or third-line standard chemotherapy regimens for advanced colorectal cancer Take Zhen-Qi-Jie-Du Granules (2 sachets, twice daily after breakfast and dinner) if assigned to the intervention group, for up to 6 months (or until treatment discontinuation criteria are met) Attend clinic visits for physical examination, vital signs, ECOG performance status assessment, laboratory blood and urine tests, chest and abdominal CT/MRI tumor imaging scans Complete validated questionnaires including FACIT-F, EORTC QLQ-C30, MDASI-TCM and the Late-Stage Colorectal Cancer TCM Syndrome Scale at scheduled visits Have adverse events, concomitant medications and survival status recorded throughout the study Provide plasma and stool biological samples at screening and scheduled follow-up visits Complete an End-of-Treatment (EOT) visit when stopping study treatment, regardless of the reason for discontinuation
Evidencia de la diana molecular en cáncer colorrectal
Aún no hay evidencia documentada en nuestra base para la diana o el fármaco de este ensayo. Esta sección crece a medida que se procesan nuevas publicaciones.
Criterios de Elegibilidad
Inclusion Criteria
Subjects meeting all of the following criteria will be eligible to participate in this study:
1. Patients with colorectal cancer who have a confirmed pathological diagnosis meeting the diagnostic criteria for the disease; patients with stage IV (MSS) colorectal cancer who are not candidates for curative surgery or who have a confirmed recurrence or metastasis post-surgery and are therefore ineligible for surgical treatment; and patients with at least one measurable lesion assessable according to RECIST 1.1 criteria.
2. Have not received prior systemic therapy for metastatic disease (enrolment in the first-line sub-arm); have failed prior first-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the second-line sub-arm); have failed prior second-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the third-line sub-arm).
3. Traditional Chinese Medicine (TCM) diagnosis consistent with TCM criteria for colorectal cancer (deficiency of both spleen and kidney, with internal obstruction by stasis and toxins).
4. Expected survival of 3 months or more.
5. Able to swallow, retain and absorb oral medication
6. Aged 18-80 years; both men and women are eligible.
7. ECOG performance status score of 0-1. Understand the details of this study, voluntarily agree to participate, and sign the informed consent form.
Note: 1. For patients with early-stage disease (e.g. stages I-III) who have undergone surgery followed by chemotherapy (e.g. as part of adjuvant therapy), the emergence of new lesions or evidence of disease recurrence during treatment or within 6 months of its completion will be considered as receiving first-line treatment for metastatic disease.2. Patients who have previously received systemic neoadjuvant chemotherapy (including in combination with radiotherapy) and who develop new lesions or evidence of disease recurrence during treatment or within 6 months of its completion will be considered to be receiving first-line treatment for metastatic disease.
Exclusion Criteria
A subject is ineligible for the study if they meet any of the following criteria:
1. A history of other malignancies within the past five years (excluding basal cell carcinoma or squamous cell carcinoma of the skin treated with curative therapy, prostatic intraepithelial neoplasia, cervical carcinoma in situ, Bowen's disease, or prostate cancer with a Gleason score ≤6).
2. Concurrent severe organic diseases affecting the cardiovascular, cerebrovascular, autoimmune, musculoskeletal, haematological, gastrointestinal, respiratory, immune, circulatory, reproductive, urinary or endocrine systems; clinically significant ECG abnormalities as assessed by the investigator; or abnormal liver or kidney function. (Normal liver and kidney function criteria: a. Serum total bilirubin ≤ 1.5 × ULN and \< 2 mg/dL. If direct (conjugated) bilirubin is ≤ 1.5 times the upper limit of normal (ULN) and indirect (unconjugated) bilirubin is ≤ 4.25 times ULN, total bilirubin \> 1.5 times ULN is permitted. b. ALT and AST ≤ 2.5 times ULN, or ≤ 5 times ULN in the presence of liver metastases.c. Estimated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula, or creatinine clearance determined via 24-hour urine collection, or according to the local institution's standard method.
3. Impaired gastrointestinal function (e.g. uncontrolled nausea, vomiting or diarrhoea, malabsorption syndrome, small bowel resection) or conditions likely to significantly alter the absorption of the oral study intervention, or recent changes in bowel function suggestive of current or impending intestinal obstruction.
4. Any unstable condition or condition that may jeopardise patient safety or compliance with the study, such as a desire to conceive, pregnancy, breastfeeding, or mental disorders including depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia.
5. Individuals with an allergy to the components of this traditional Chinese medicine.
6. Patients receiving other treatments prior to enrolment that may affect the efficacy assessment of this trial.
7. Patients who have recently participated in or are currently participating in clinical trials of other drugs.
8. Any other circumstances deemed unsuitable for inclusion by the investigator.